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Remote CER/Medical Writer

Company: Aerotek
Location: Santa Ana
Posted on: January 15, 2022

Job Description:

REMOTE MEDICAL WRITER/CER WRITER Openings (2) - Leading Medical Device Company!Openings: hiring 2 Medical Writers - various levels hiring, please review details below!Location:100% Remote home office based anywhere in the US/CanadaCompany:Leading Medical Device company, strong opportunity for growth and developmentJob Description:

  • Support the preparation of regulatory documents and responses to regulatory authorities (with a focus on medical device products).
  • Contribute to the writing of the following document types (in accordance to SOP(s), clients guidelines and regulatory requirements) (list is not exhaustive):
    • Clinical Evaluation Plan (CEP)
    • Clinical Evaluation Report (CER)
    • Post-market Clinical Follow-up Plan (PMCF-P)
    • Post-market Clinical Follow-up Report (PMCF-R)
    • Safety and Clinical Performance Reports (SSCP-R)
    • Perform critical review and data analysis from clinical investigations and literature for incorporation into the CER.
    • Combine understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices.
    • Support the preparation of regulatory documents and responses to regulatory authorities.
    • Will proactively partner (in conjunction with the Technical Writing Manager) with cross functional business partners such as Medical Affairs, PMS staff, Quality, R&D, Regulatory Affairs, other vendors relating to the CER process.
    • May perform routine systematic literature reviews for specific medical devices.
    • May participate in workshops and company initiatives to help define processes globally and provide timely CER regulatory requirements and industry best practices for continuous process improvementQualifications:
      • Open to candidates with either of the following backgrounds:
        • 1. PhD with medical device exposure and strong literature review experience (can be trained in CER writing/clinical but needs foundation in med device & literature review) OR
        • 2. Bachelors with 3+ years experience in CER/EU MDR writing
        • Familiarity with Medical Device is requiredCompensation:Rate flexible based on experience, W2includes paid holiday, paid vacation, optional benefits - Long term opportunity through embedded service provider, opportunity for career development, advancement and exposure to a variety of product lines!The following information is provided for Colorado based candidates: Compensation is tied to the Colorado market for jobs performed in Colorado.Other locations may be subject to variances basedon locations-related factors.We reserve the right to pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classification.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits aresubject to change and may be subject to specific elections, plan, or programterms.This temporary role may be eligible for the following:
          • Medical,dental & vision
          • 401(k)/Roth
          • Insurance(Basic/Supplemental Life & AD&D)
          • Shortand long-term disability
          • Health& Dependent Care Spending Accounts (HSA & DCFSA)
          • Transportationbenefits
          • EmployeeAssistance Program
          • TimeOff/Leave (PTO, Vacation or Sick Leave) About Actalent:Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. Were supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Santa Ana , Remote CER/Medical Writer, Healthcare , Santa Ana, California

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